CE Auditor Using ISO audit reports to show compliance to the MDD??

lboll

Involved In Discussions
#1
I have encountered a company that uses Notified Body "A" as their ISO 13485 auditor and NB "D" as their CE auditor to the MDD 93/42/EEC.
When I asked to review their last few CE audit reports, the company told me that NB "D" does not do on-site audits - they use the ISO audit reports from NB "A" as assurance of compliance.

I know there is no way an ISO 13485 audit report can be used to show compliance with the MDD 93/42/EEC because there are very significant differences.

My question is - has anyone ever encountered a NB that would use this practice? I really question it because the NB in question is reputable and I'm not really buying the company's explanation.
 
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somashekar

Leader
Admin
#2
MDD 93/42/EEC is a regulatory requirement and ISO13485 QMS is the base QMS that is constructed including this MDD requirement and any other regulatory requirement to which you want to align.
NB "D" must be happy to use the CB "A" report, but I am sure they will audit your technical file to its current levels.
 

pkost

Trusted Information Resource
#3
ISO 13485 is a harmonised standard, therefore if you comply with ISO13485 (and can demonstrate this with a certificate issued by an accredited certification body) then your notified body (responsible for approving your use of a CE) has to assume compliance with the QMS requirements of the medical device directive.

Depending on the conformity assessment route (I'm assuming Annex II) then the two main aspects are: the QMS and technical file.

If the manufacturer has ISO13485, this leaves only the technical file for review. Technical files are frequently reviewed remotely by the notified body as it is a file and there is little to be gained from a site audit.

That being said, our notified body conducted a "site" audit to sample our technical files recently...they stayed in the meeting room and just requested files.
 

lboll

Involved In Discussions
#4
The CE Certificate of Conformity issued by NB "D" is stating compliance with Annex V of the EC Directive 93/42/EEC.
 

Avraham Harris

Involved In Discussions
#5
The CE Certificate of Conformity issued by NB "D" is stating compliance with Annex V of the EC Directive 93/42/EEC.
Sorry lboll, but I did not understand your last comment. what do you mean by it?

I found the following blog to be a very helpful resource regarding Annex V and that seems to answer your main concern - yes you are correct it should be on-site, at least according to Dr. D.

https://www.medtechintelligence.com/column/devine-guidance-mdd-annex-v/

thanks,
Avraham
 
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